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Drug overview for IMAAVY (nipocalimab-aahu):
Generic name: NIPOCALIMAB-AAHU (NIP-oh-KAL-i-mab)
Drug class: Antimyasthenic Agents
Therapeutic class: Locomotor System
Nipocalimab-aahu, a human IgG1 monoclonal antibody, is a neonatal Fc receptor blocker.
No enhanced Uses information available for this drug.
Generic name: NIPOCALIMAB-AAHU (NIP-oh-KAL-i-mab)
Drug class: Antimyasthenic Agents
Therapeutic class: Locomotor System
Nipocalimab-aahu, a human IgG1 monoclonal antibody, is a neonatal Fc receptor blocker.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for IMAAVY (nipocalimab-aahu) have been approved by the FDA:
Indications:
Anti-acetylcholine receptor (AChR) antibody positive generalized myasthenia gravis
Anti-muscle-specific tyrosine kinase (MuSK) antibody positive generalized myasthenia gravis
Professional Synonyms:
AChR-Ab(+) generalized myasthenia gravis
Indications:
Anti-acetylcholine receptor (AChR) antibody positive generalized myasthenia gravis
Anti-muscle-specific tyrosine kinase (MuSK) antibody positive generalized myasthenia gravis
Professional Synonyms:
AChR-Ab(+) generalized myasthenia gravis
The following dosing information is available for IMAAVY (nipocalimab-aahu):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| IMAAVY 1,200 MG/6.5 ML VIAL | Maintenance | Adults infuse 15 mg/kg over at least 15 minute(s) by intravenous route every 2 weeks |
No generic dosing information available.
The following drug interaction information is available for IMAAVY (nipocalimab-aahu):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Live Vaccines; Live BCG/Selected Immunosuppressive Agents SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1) CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2) PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency. PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1) |
ACAM2000 (NATIONAL STOCKPILE), ADENOVIRUS TYPE 4, ADENOVIRUS TYPE 4 AND TYPE 7, ADENOVIRUS TYPE 7, BCG (TICE STRAIN), BCG VACCINE (TICE STRAIN), DENGVAXIA, ERVEBO (NATIONAL STOCKPILE), FLUMIST 2025-2026, FLUMIST HOME 2025-2026, IXCHIQ, M-M-R II VACCINE, PRIORIX, PROQUAD, ROTARIX, ROTATEQ, STAMARIL, VARIVAX VACCINE, VAXCHORA ACTIVE COMPONENT, VAXCHORA VACCINE, VIVOTIF, YF-VAX |
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Nipocalimab-aahu SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3) |
ABRILADA(CF), ABRILADA(CF) PEN, ABRILADA(CF) PEN (2 PACK), ACTEMRA, ACTEMRA ACTPEN, ADALIMUMAB-AACF(CF), ADALIMUMAB-AACF(CF) (2 PK), ADALIMUMAB-AACF(CF) PEN (2 PK), ADALIMUMAB-AACF(CF) PEN CROHNS, ADALIMUMAB-AACF(CF) PEN PS-UV, ADALIMUMAB-AATY(CF) (2 PACK), ADALIMUMAB-AATY(CF) (2 PK), ADALIMUMAB-AATY(CF) AI CROHNS, ADALIMUMAB-AATY(CF) AUTOINJ(2), ADALIMUMAB-AATY(CF) AUTOINJECT, ADALIMUMAB-ADAZ(CF), ADALIMUMAB-ADAZ(CF) PEN, ADALIMUMAB-ADBM(CF), ADALIMUMAB-ADBM(CF) PEN, ADALIMUMAB-ADBM(CF) PEN CROHNS, ADALIMUMAB-ADBM(CF) PEN PS-UV, ADALIMUMAB-ADBM(CF)PEN, ADALIMUMAB-FKJP(CF), ADALIMUMAB-FKJP(CF) PEN, ADALIMUMAB-RYVK(CF), ADALIMUMAB-RYVK(CF) AUTOINJECT, ADBRY, ADBRY AUTOINJECTOR, ADCETRIS, AIMOVIG AUTOINJECTOR, ALHEMO PEN, ALPROLIX, ALYGLO, ALYMSYS, AMJEVITA(CF), AMJEVITA(CF) AUTOINJECTOR, ANDEMBRY AUTOINJECTOR, ANTHRASIL (NATIONAL STOCKPILE), ARZERRA, ASCENIV, ATGAM, AVASTIN, AVSOLA, BAVENCIO, BENLYSTA, BEYFORTUS, BIMZELX, BIMZELX AUTOINJECTOR, BIVIGAM, BIZENGRI, BKEMV, BOMYNTRA, BOTULISM ANTITOXIN HEPTAVALENT, BRIUMVI, CAMPATH, CNJ-016 (NATIONAL STOCKPILE), COLUMVI, CONEXXENCE, COSENTYX, COSENTYX (2 SYRINGES), COSENTYX SENSOREADY (2 PENS), COSENTYX SENSOREADY PEN, COSENTYX SYRINGE, COSENTYX UNOREADY PEN, CUTAQUIG, CUVITRU, CYLTEZO(CF), CYLTEZO(CF) PEN, CYLTEZO(CF) PEN CROHN'S-UC-HS, CYLTEZO(CF) PEN PSORIASIS-UV, CYTOGAM, DANYELZA, DARZALEX, DARZALEX FASPRO, DATROWAY, DUPIXENT PEN, DUPIXENT SYRINGE, EBGLYSS PEN, EBGLYSS SYRINGE, ELAHERE, ELOCTATE, ELREXFIO, EMGALITY PEN, EMGALITY SYRINGE, EMRELIS, ENBREL, ENBREL MINI, ENBREL SURECLICK, ENFLONSIA, ENHERTU, ENJAYMO, ENTYVIO, ENTYVIO PEN, EPKINLY, EPYSQLI, EVENITY, EVENITY (2 SYRINGES), EVKEEZA, FASENRA, FASENRA PEN, FLEBOGAMMA DIF, GAMASTAN, GAMIFANT, GAMMAGARD LIQUID, GAMMAGARD S-D, GAMMAKED, GAMMAPLEX, GAMUNEX-C, GOHIBIC (EUA), HADLIMA, HADLIMA PUSHTOUCH, HADLIMA(CF), HADLIMA(CF) PUSHTOUCH, HEMLIBRA, HEPAGAM B, HERCEPTIN, HERCEPTIN HYLECTA, HERCESSI, HERZUMA, HIZENTRA, HULIO(CF), HULIO(CF) PEN, HUMIRA, HUMIRA PEN, HUMIRA(CF), HUMIRA(CF) PEN, HUMIRA(CF) PEN CROHN'S-UC-HS, HUMIRA(CF) PEN PSOR-UV-ADOL HS, HYMPAVZI PEN, HYPERHEP B, HYPERRAB, HYPERRHO S-D, HYPERTET, HYQVIA, HYQVIA IG COMPONENT, HYRIMOZ(CF), HYRIMOZ(CF) PEDIATRIC CROHN'S, HYRIMOZ(CF) PEN, HYRIMOZ(CF) PEN CROHN-UC START, HYRIMOZ(CF) PEN PSORIASIS, ILARIS, ILUMYA, IMFINZI, IMJUDO, IMOGAM RABIES-HT, IMULDOSA, INFLECTRA, INFLIXIMAB, JEMPERLI, JUBBONTI, KADCYLA, KANJINTI, KEDRAB, KESIMPTA PEN, KEVZARA, KEYTRUDA, KISUNLA, LEMTRADA, LEQEMBI, LIBTAYO, LOQTORZI, LUNSUMIO, LYNOZYFIC, MVASI, MYLOTARG, NABI-HB, NEMLUVIO, NIKTIMVO, NUCALA, NULOJIX, OCTAGAM, OGIVRI, OMVOH, OMVOH PEN, ONTRUZANT, OPDIVO, OPDIVO QVANTIG, OPDUALAG, OSENVELT, OTULFI, PADCEV, PANZYGA, PEMGARDA (EUA), PHESGO, PIASKY, POLIVY, POTELIGEO, PRALUENT PEN, PRIVIGEN, PROLIA, PYZCHIVA, REMICADE, RENFLEXIS, RHOGAM ULTRA-FILTERED PLUS, RHOPHYLAC, RIABNI, RITUXAN, RITUXAN HYCELA, RUXIENCE, RYBREVANT, RYZNEUTA, SELARSDI, SILIQ, SIMLANDI(CF), SIMLANDI(CF) AUTOINJECTOR, SIMULECT, SKYRIZI, SKYRIZI ON-BODY, SKYRIZI PEN, SOLIRIS, SPEVIGO, STELARA, STEQEYMA, STOBOCLO, TALTZ AUTOINJECTOR, TALTZ AUTOINJECTOR (2 PACK), TALTZ AUTOINJECTOR (3 PACK), TALTZ SYRINGE, TALVEY, TECENTRIQ, TECENTRIQ HYBREZA, TECVAYLI, TEPEZZA, TEVIMBRA, TEZSPIRE, THYMOGLOBULIN, TIVDAK, TOFIDENCE, TRAZIMERA, TREMFYA, TREMFYA ONE-PRESS, TREMFYA PEN, TREMFYA PEN INDUCTION PK-CROHN, TRODELVY, TROGARZO, TRUXIMA, TYENNE, TYENNE AUTOINJECTOR, TYSABRI, TZIELD, ULTOMIRIS, UNITUXIN, USTEKINUMAB, USTEKINUMAB-AEKN, USTEKINUMAB-TTWE, VARIZIG, VEGZELMA, VEOPOZ, VYLOY, WEZLANA, WINREVAIR, WINREVAIR (2 PACK), WINRHO SDF, WYOST, XEMBIFY, XGEVA, XOLAIR, YERVOY, YESINTEK, YUFLYMA(CF) (2 PACK), YUFLYMA(CF) AI CROHN'S-UC-HS, YUFLYMA(CF) AUTOINJECT (2 PCK), YUFLYMA(CF) AUTOINJECTOR, YUSIMRY(CF) PEN, ZEVALIN, ZIIHERA, ZINPLAVA, ZIRABEV, ZYMFENTRA, ZYMFENTRA (2 PACK), ZYMFENTRA PEN (2 PACK), ZYNLONTA, ZYNYZ |
There are 0 moderate interactions.
The following contraindication information is available for IMAAVY (nipocalimab-aahu):
Drug contraindication overview.
Nipocalimab-aahu is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab or to any of the excipients in the formulation.
Nipocalimab-aahu is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab or to any of the excipients in the formulation.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Infection |
There are 0 moderate contraindications.
The following adverse reaction information is available for IMAAVY (nipocalimab-aahu):
Adverse reaction overview.
The most common adverse reactions (>=10%) in patients with gMG treated with nipocalimab-aahu were respiratory tract infections, peripheral edema, and muscle spasms.
The most common adverse reactions (>=10%) in patients with gMG treated with nipocalimab-aahu were respiratory tract infections, peripheral edema, and muscle spasms.
There are 0 severe adverse reactions.
There are 24 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Muscle spasm Peripheral edema Upper respiratory infection |
Acute abdominal pain Anemia Back pain Cough Dental abscess Diarrhea Dizziness Fever Herpes simplex infection Herpes zoster Hyperlipidemia Hypersensitivity drug reaction Hypertension Influenza Injection site sequelae Insomnia Lower respiratory infection Nausea Oral candidiasis Skin and skin structure infection Urinary tract infection |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for IMAAVY (nipocalimab-aahu):
The safety and effectiveness of nipocalimab-aahu for the treatment of generalized myasthenia gravis (gMG) have been established in pediatric patients 12 years of age and older. Use of nipocalimab-aahu in pediatric patients for this indication is supported by evidence from an adequate and well-controlled trial in adults with additional pharmacokinetic and safety data in pediatric patients 12 years of age and older. Safety and effectiveness of nipocalimab-aahu for the treatment of gMG in pediatric patients below the age of 12 years have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are limited data on the use of nipocalimab-aahu in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There was no evidence of direct adverse effects on fetal development following administration of nipocalimab-aahu to pregnant monkeys; however, adverse effects on the placenta were associated with fetal loss at both doses tested. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There is a pregnancy safety study for nipocalimab-aahu. If nipocalimab-aahu is administered during pregnancy, or if a patient becomes pregnant while receiving nipocalimab-aahu, healthcare providers should report nipocalimab-aahu exposure by contacting Janssen at 1-800-526-7736.
Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Because nipocalimab-aahu reduces maternal serum IgG concentration and impedes placental IgG transfer to the fetus, passive immunity in the infant may be reduced for 6 months or more. The effectiveness of vaccines may be reduced. Consider the risks and benefits prior to administering live vaccines to infants exposed to nipocalimab-aahu in utero.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There is a pregnancy safety study for nipocalimab-aahu. If nipocalimab-aahu is administered during pregnancy, or if a patient becomes pregnant while receiving nipocalimab-aahu, healthcare providers should report nipocalimab-aahu exposure by contacting Janssen at 1-800-526-7736.
Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Because nipocalimab-aahu reduces maternal serum IgG concentration and impedes placental IgG transfer to the fetus, passive immunity in the infant may be reduced for 6 months or more. The effectiveness of vaccines may be reduced. Consider the risks and benefits prior to administering live vaccines to infants exposed to nipocalimab-aahu in utero.
Nipocalimab-aahu is excreted in human colostrum and breastmilk based on limited data from an investigational study of 13 pregnant women administered the drug during pregnancy where colostrum and breastmilk was assessed in the first 8 days after birth. There are insufficient data on the effect of nipocalimab-aahu in the breastfed infant. There are no data on the effect of nipocalimab on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for nipocalimab-aahu, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Clinical studies of nipocalimab-aahu did not include sufficient numbers of patients 65 years of age and over to determine whether they respond differently from younger adult patients.
The following prioritized warning is available for IMAAVY (nipocalimab-aahu):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for IMAAVY (nipocalimab-aahu)'s list of indications:
| AchR antibody positive generalized myasthenia gravis | |
| G70.0 | Myasthenia gravis |
| G70.00 | Myasthenia gravis without (acute) exacerbation |
| G70.01 | Myasthenia gravis with (acute) exacerbation |
| MuSK antibody positive generalized myasthenia gravis | |
| G70.0 | Myasthenia gravis |
| G70.00 | Myasthenia gravis without (acute) exacerbation |
| G70.01 | Myasthenia gravis with (acute) exacerbation |
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